Efficacy and Safety of Litramine in 1 Year Weight Loss Study

NCT ID: NCT03227276

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2020-02-19

Brief Summary

To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects

Conditions

Obesity; Excess Calories; Overweight and Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DIETARY_SUPPLEMENT

2 tablets to be taken 3 times a day after meals

Litramine

Group Type: EXPERIMENTAL

Litramine

Intervention Type: DIETARY_SUPPLEMENT

2 tablets to be taken 3 times a day after meals

Interventions

Litramine

2 tablets to be taken 3 times a day after meals

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablet

2 tablets to be taken 3 times a day after meals

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Men and women from 18 to 70 years old

2. Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI 30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects

3. Generally in good health

4. Desire to lose weight

5. Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview

6. Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)

7. Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self- reported change)

8. Subject's agreement to comply with study procedures, in particular:

• to take IP as recommended
• to avoid the use of other weight loss and/or management products and/or programs during the study
• to adhere to diet recommendation during the study
• to complete the subject diary and study questionnaires

9. Women of childbearing potential:

• commitment to use contraception methods
• negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

10. Written informed consent

Exclusion Criteria

1. Known allergy or hypersensitivity to the components of the investigational products or source plants

2. Pathological electrocardiogram (ECG) at V1

3. History and/or presence of clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:

• untreated or unstable thyroid gland disorder
• untreated or unstable hypertension (regular blood pressure >140/90 mm Hg)
• acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g.

inflammatory bowel disease, coeliac disease, pancreatitis etc.)

• diabetes mellitus type 1
• untreated or unstable diabetes mellitus type 2
• any other serious organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject

4. Significant surgery within the last 6 months prior to V1:

• GI surgery
• liposuction

5. History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1

6. Deviation of safety laboratory parameter(s) at V1 that is:

• clinically significant or
• >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)

7. Any electronic medical implant

8. Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:

• that could influence body weight (e.g. systemic corticosteroids)
• that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.) as per investigator judgement
• for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)

9. Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)

10. Women of child-bearing potential: pregnancy or nursing

11. History of or current abuse of drugs, alcohol or medication

12. Participation in another clinical study in the 30 days prior to V1 and during the study

13. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Udo Bongartz, MD

Role: PRINCIPAL_INVESTIGATOR

Analyze & Realize

Locations

Analyze & Realize

Berlin, , Germany

Countries

Germany

Other Identifiers

INQ/004317

Identifier Type: -

Identifier Source: org_study_id